InfluenzaPhase 2NCT00540592
Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
A Phase 2 study testing GlaxoSmithKline Biologicals' influenza vaccine GSK576389A and Fluarix in people with Influenza, run by GlaxoSmithKline at 30 sites in 4 countries.
Trial summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GlaxoSmithKline Biologicals' influenza vaccine GSK576389A and Fluarix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,007 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 8 Oct 2007to 10 Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol during the entire study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
- Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Hypersensitivity to a previous dose of influenza vaccine.
- Allergy to any component of the vaccine.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated.
- Lactating female or female planning to become pregnant or to discontinue contraceptive precautions
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
Germany20 sites
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Berlin, 10435
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Berlin, 13359
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Freital, Saxony, 01705
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363
GSK Investigational Site
Hamburg, 22335
GSK Investigational Site
Hamburg, 22415
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Rudersberg, Baden-Wurttemberg, 73635
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326
United Kingdom5 sites
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA
GSK Investigational Site
Clydebank, Glasgow, G81 2DR
GSK Investigational Site
Edgbaston, Birmingham, B15 2SQ
GSK Investigational Site
Reading, Berkshire, RG2 0TG
GSK Investigational Site
Waterloo, Liverpool, L22 0LG
Sweden3 sites
GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Karlskrona, SE-371 41
GSK Investigational Site
Uppsala, SE-751 85
Netherlands2 sites
GSK Investigational Site
Rotterdam, 3011 EN
GSK Investigational Site
Rotterdam, 3015 GE
About this study
Official title: Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Read the detailed description
There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18 and 40 years old receiving Fluarix. CMI response will be determined for a subset only.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Influenza
- Being tested
- GlaxoSmithKline Biologicals' influenza vaccine GSK576389A, Fluarix
- Keywords
- Influenza vaccine GSK576389A, Influenza infection, Fluarix
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlaxoSmithKline Biologicals' influenza vaccine GSK576389ABiological
Single dose, Intramuscular injection, 8 different formulations were tested (one per group)
FluarixBiological
Single dose, Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine GSK576389A formulation 1 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 2 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 3 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 4 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 5 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 6 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 7 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Influenza vaccine GSK576389A formulation 8 Group | Experimental | Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A. Receives: Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A |
| Fluarix elderly Group | Active comparator | Subjects aged ≥65 years received one dose of Fluarix vaccine. Receives: Biological: Fluarix |
| Fluarix young Group | Active comparator | Subjects aged 18-40 years received one dose of Fluarix vaccine. Receives: Biological: Fluarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
Secondary outcomes (21)
HI Antibody Titers at Day 0 and Day 21
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 0 and 21
HI Antibody Titers at Day 180
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 180
HI Antibody Seroconversion Factors at Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
HI Antibody Seroconversion Factors at Day 180
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 180
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 0 and 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 180
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Days 0 and 21
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 180
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Days 0 and 21
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 180
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Measured: Between Day 0 and Day 20 after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Measured: Between Day 21 and Day 179 after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: Between Day 0 and Day 20 after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: Between Day 21 and Day 179 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study start8 Oct 2007
- Primary completion10 Jun 2008
- Study completion10 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540592
- Sponsor's protocol ID
- 110847
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2007
- Last updated
- 8 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.
PubMed 23890405
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
- ClinicalTrials.gov ID
- NCT00540592
- Acronym / sponsor ID
- 110847
- Conditions
- Influenza
- Keywords
- Influenza vaccine GSK576389A, Influenza infection, Fluarix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,007 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2007
- Primary completion
- 10 Jun 2008 (actual)
- Study completion
- 10 Jun 2008 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Posted 30 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Detailed description
There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18 and 40 years old receiving Fluarix. CMI response will be determined for a subset only.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine GSK576389A formulation 1 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 2 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 3 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 4 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 5 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 6 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 7 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 8 Group | Experimental | Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASubjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A. |
| Fluarix elderly Group | Active comparator | Biological: FluarixSubjects aged ≥65 years received one dose of Fluarix vaccine. |
| Fluarix young Group | Active comparator | Biological: FluarixSubjects aged 18-40 years received one dose of Fluarix vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Key exclusion criteria (14 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol during the entire study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlaxoSmithKline Biologicals' influenza vaccine GSK576389ASingle dose, Intramuscular injection, 8 different formulations were tested (one per group) | Biological | Influenza vaccine GSK576389A formulation 1 Group, Influenza vaccine GSK576389A formulation 2 Group, Influenza vaccine GSK576389A formulation 3 Group, Influenza vaccine GSK576389A formulation 4 Group, Influenza vaccine GSK576389A formulation 5 Group, Influenza vaccine GSK576389A formulation 6 Group, Influenza vaccine GSK576389A formulation 7 Group, Influenza vaccine GSK576389A formulation 8 Group |
| FluarixSingle dose, Intramuscular injection | Biological | Fluarix elderly Group, Fluarix young Group |
Primary outcome
Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Day 21
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
21 secondary outcomes
HI Antibody Titers at Day 0 and Day 21
Time frame: At Day 0 and 21
HI Antibody Titers at Day 180
Time frame: At Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Time frame: At Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Time frame: At Day 180
HI Antibody Seroconversion Factors at Day 21
Time frame: At Day 21
HI Antibody Seroconversion Factors at Day 180
Time frame: At Day 180
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21
Time frame: At Day 0 and 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
Time frame: At Day 180
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
Time frame: At Days 0 and 21
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
Time frame: At Day 180
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
Time frame: At Days 0 and 21
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
Time frame: At Day 180
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited Local AEs
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited General AEs
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20
Time frame: Between Day 0 and Day 20 after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179
Time frame: Between Day 21 and Day 179 after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20
Time frame: Between Day 0 and Day 20 after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179
Time frame: Between Day 21 and Day 179 after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23890405Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GlaxoSmithKline Biologicals' influenza vaccine GSK576389A and Fluarix in people with Influenza, run by GlaxoSmithKline at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, United Kingdom, Sweden, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemagglutination Inhibition (HI) Antibody Titers (time frame: At Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.